NCT05890365 Increased Risk of Non-alcoholic Fatty Liver Disease in Low Birth Weight Individuals
| NCT ID | NCT05890365 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Steno Diabetes Center Copenhagen |
| Condition | Non-Alcoholic Fatty Liver Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2023-12-14 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2023-12-14 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The investigators recently demonstrated a increase in liver fat in early middle-aged LBW compared to normal birth weight (NBW) men, and 20% of the LBW - but none of the normal birth weight (NBW) - men had previously unknown non-alcoholic fatty liver disease (NAFLD). Here the investigators will further examine the Increased risk of non-alcoholic fatty liver disease in low birth weight individuals by performing a validation study.
Eligibility Criteria
Inclusion Criteria: * 250 healthy, men and women born with a low birth weight (birth weight (BW) \<10% of the population) and 50 born with a normal birth weight controls (BW between 50-90% of the population) * born at term (weeks 39-41) Exclusion Criteria: * BMI\>35 kg/m2 * Disease/medication known to affect primary outcome * Self-reported high physical activity level * Alcohol intake above general recommendations. * Metabolic/liver disease * Weight gain/loss of \>3 kg within the past 6 months
Contact & Investigator
Allan Vaag, MD, PhD
STUDY DIRECTOR
Steno Diabetes Center Copenhagen
Frequently Asked Questions
Who can join the NCT05890365 clinical trial?
This trial is open to participants of all sexes, aged 34 Years or older, up to 49 Years, studying Non-Alcoholic Fatty Liver Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05890365 currently recruiting?
Yes, NCT05890365 is actively recruiting participants. Contact the research team at charlotte.broens.01@regionh.dk for enrollment information.
Where is the NCT05890365 trial being conducted?
This trial is being conducted at Herlev, Denmark.
Who is sponsoring the NCT05890365 clinical trial?
NCT05890365 is sponsored by Steno Diabetes Center Copenhagen. The principal investigator is Allan Vaag, MD, PhD at Steno Diabetes Center Copenhagen. The trial plans to enroll 300 participants.